Clinical Trials Logo

Clinical Trial Summary

This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Patients were randomized into a health coaching group and a usual care group. Those in the health coaching group received 9 months of active health coaching. Outcome variables were measured at baseline and after 9 months


Clinical Trial Description

Health coaching is a promising model for improving evidence-based care for patients with COPD which had not been evaluated at the time the current study began in 2014. Health coaching by health workers or peers trained as coaches, has emerged as an effective model to improve these management domains for children with asthma and adults with diabetes, and hypertension receiving care in urban safety-net clinics. The role of the health coach includes many of the activities also provided by patient navigators, patient educators, and community health workers. Health coaching is a patient-centered model that recognizes that that people living with chronic disease are the primary decision-makers in their care; it is a tailored approach that builds on the strengths and expertise of patients and helps to ensure that they have the knowledge and skills to be active participants within the medical encounter and to effectively manage their conditions. Incorporating health coaches into care delivery fits well with the of integrated care model recommended by the American Thoracic Society which is based on the Chronic Care Mode. Health coaching can work on several components of the Chronic Care Model as it applies to COPD to enhance the effectiveness of care delivery and promote patient goals. Health coaches provide decision support by helping execute customized care plans jointly developed by patients and providers. Coaches track care targets and conduct 'gap analysis' to identify areas which are sub-optimal. Coaches also help patients to get the support they need by facilitating access to community, clinic, and specialist support, improving communication between patients and providers, working with patients to set goals and develop action plans to reach those goals. The goal of our study was to evaluate the effectiveness of a health coach model for improving outcomes for low-income urban patients with COPD. We conducted a randomized trial comparing 9 months of health coaching plus usual care (health coached arm) to usual care (usual care arm) alone for patients with moderate to severe COPD cared for at 7 federally qualified health centers (FQHCs). The specific aims of the study were:

Specific Aim 1. To compare disease specific quality of life for patients randomized to receive 9 months of health coaching plus usual care to those randomized to usual care alone. Our hypothesis was that mean quality of life, assessed by the Chronic Respiratory Disease Questionnaire total score and dyspnea domain score at 9 months, would be greater in patients in the health-coached arm when tested against the null hypothesis of no difference between health-coached and usual care patients.

Specific Aim 2. To compare the number of exacerbations of COPD experienced by patients in the health coached arm to those in the usual care arm during the 9 month period starting at enrollment. COPD exacerbation was defined as an emergency department visit or hospitalization for COPD-related diagnosis or the outpatient prescription of oral steroids for COPD-related diagnosis. Our hypothesis was patients in the health-coached arm would experience fewer exacerbations when tested against the null hypothesis of no difference between health-coached and usual care patients.

Specific Aim 3. To compare exercise capacity at 9 months for patients in the health-coached arm to those in the usual care arm. Our hypothesis was that patients in the health-coached arm would have greater exercises capacity as measured by the 6-minute Walk Test when tested against the null hypothesis of no difference between health-coached and usual care patients.

Specific Aim 4. To compare self-efficacy for management of their COPD for health-coached versus usual care patients at 9 months. Our hypothesis was that mean self-efficacy, as measured by Stanford Chronic Disease Self-Efficacy Scale would be greater in patients in the health coached arm when tested against the null hypothesis of no difference in self-efficacy between health-coached and usual care patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02234284
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase N/A
Start date November 12, 2014
Completion date May 4, 2017

See also
  Status Clinical Trial Phase
Completed NCT03282019 - Study of Long-term HFNC for COPD Patients With HOT N/A
Completed NCT05573464 - A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease Phase 3
Recruiting NCT06040086 - Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations Phase 3
Not yet recruiting NCT06376994 - Multi-Center Clean Air Randomized Controlled Trial in COPD Phase 3
Completed NCT02926534 - Cross-Sectional Study of COPD Prevalence Among Smokers, Ex-smokers and Never-Smokers in Almaty, Kazakhstan N/A
Completed NCT02728674 - Management of Patients With Respiratory Symptoms in Sweden N/A
Completed NCT02797392 - Feasibility of a Preventive Program Against Lifestyle Related Diseases N/A
Recruiting NCT02415478 - Bronchioscopic Lung Volume Reduction (BLVR) N/A
Completed NCT03487406 - Anti-platelet Therapy in the Prevention of Cardiovascular Disease in Patients With COPD (APPLE-COPD: ICON 2) Phase 2
Completed NCT02459080 - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT02518139 - A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT02774226 - Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02512510 - Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01893476 - A Pragmatic Cluster Trial of a Tailored Intervention to Improve COPD Management N/A
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Withdrawn NCT01908933 - Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema Phase 3
Completed NCT01908140 - Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01701869 - Microbiology & Immunology of the Chronically-inflamed Airway N/A
Recruiting NCT02527486 - Seoul National University Airway Registry N/A
Terminated NCT01388920 - Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting Phase 2